Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1278-2012

Permolock C3, Docking system for Power wheelchair in vehicle

Permobil, AB / initiated 2012-02-21 / Terminated / root cause: manufacturing process

Permobil Inc began a recall of Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device on . The reason FDA records is "The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1278-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Permobil, AB
Product
Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device
Product code
KNN Components, Wheelchair
Reason for recall
The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure attachment.
Root cause tag
manufacturing process
FDA root cause
Mixed-up of materials/components
Action
The firm, Permobil, sent an "URGENT DEVICE RECALL" letter dated February 27, 2012 via fax to all customers. For those customers where Permobil did not have a valid fax number, the notices were mailed via first class United States mail. The letter describes the product, problem and actions to be taken. Permobil will designate Permobil personnel to complete an update to the Permolock C3 device. If a Permobil representative has not contacted you already, please call 800-736-0925 to schedule the service.
Quantity in commerce
147 units
Distribution
Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, MD ,MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WV, and WY; and countries of: Australia, Canada, France, Netherlands, Sweden, and United Kingdom.
Product codes and lots
2535004066, 2572002096, 2579000034, 2572000426, 2572000849, 2572002091, 2572000465, 2535004075, 2535005133, 2535005713, 2572000634, 2572000657, 2572000990, 2572001078, 2572001083, 2572001160, 2572001164, 2572001165, 2572001358, 2572001374, 2572001421, 2572001853, 2572002187, 2572003372, 2579000098, 2579000113, 2579000116, 2579000118, 2535005348, 2572001751, 2535005269, 2572000413, 2579000074, 2579000142, 2535003842, 2535003900, 2535003840, 2572002439, 2572002766, 2572003182,  XXX(missing), 2579000063, 2572000759, 2572002123, 2579000069, 2572001763, 2535004162, 2572001946, 2532000044, 2535003732, 2535005475, 2572002189, 2579000151, 2579000156, 2535005551, 2535005774, 2572001705, 2579000089, 2539000224, 43203318, 2579000143, 2535004819, 2572002020, 2572002080, 2572002169, 2572002417, 2579000127, 2572000754, 2572001116, 2572001646, 2572001852, 2573000016, 2573000027, 2573000028, 2573000029, 2535004353, 2535004564, 2535004586, 2539000222, 2539000277, 2539000310, 2539000344, 2572000639, 2572001038, 2572001445, 2572001631, 2572001981, 2572002686, 2579000067, 2535005151, 2535005113, 2572002831, 2572002863, 2535005645, 2535005730, 2539000263, 2572000826, 2572002659, 2535004730, 2535005300, 2535005579, 2572000688, 2572002040, 2572002801, 2535003865, 2535004016, 2535005131, 2572002425, 2579000082, 2535004413, 2535005463, 2572000540, 2535004285, 2572003051, 2535005557, 2572003293, 2579000045, 2572000785, 2532000016, 2535004732, 2572001708, 2572002155, 2572000424, 2535004060, 2535003525, 2572000552, 2572001632, 2572002511, 2572002519, 2572001711, 2535004620, 2572001807, 2535004136, 2572002062, 2572003093, 2572001549, 2572002110, 2572002599, 2572002694, 2535005406, 2572001821, 2535004688, 2535004912, 2572000894,2572003240, 2579000090, 2539000332